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Good points all. Especially when you throw in the variable at the other sites where you actually inspect the syringes. Like I said, they told me part of the protocol was to NOT look at the syringe.

Bob, I think they have to ship the drug with the placebo or that would mean that there are people at Opexa who are also unblinded. I don't think that anyone at Opexa is unblinded but I may be wrong. Reading back through all these posts it is clearly evident that each site, while supposedly following the protocol, is very different. My site is a very relaxed atmosphere and I feel very comfortable with Lyle (my coord.) and Jim (my nurse). We laugh and joke and generally have a relaxing time. Jim is mountain gorilla sized, but that's where it stops. He's just a big ol' country boy from a rural area around here and he's so soft spoken he's like anti intimidating, but he is a house. He's not only tall, but he's "farm boy" big too. He probably weighs 300 easy and he's only a bit overweight.

Anyway, someone should see if the entire protocol is available for us to read. I don't think it would be off limits, but the stark contrast between "don't turn around" and "please inspect the syringe" have piqued my curiousity. Come March (my 1st shots) I will definitely be grilling Jim on the exact procedure and the purpose for his request of me to not look at the syringes. I'll email my coordinator about it on Monday and see if he's forthcoming with any info.

Right now I have to start my 48 hour preparation period before the Buckeyes embarass LSU! I fart in the general direction of all Bayou Bengal fans.

Maybe I should clarify; The package that has been delivered to the clinic for me waits unopened on the counter until we are ready to inject. The box is opened in front of me, the vials are removed and presented to me so that I can verify the name on them (maybe I should look for someone else's name). The vials are clear glass so that I can see what is inside. I am absolutely sure that at least one of my visits produced "tea colored" vials and the rest seemed clear. I think it is clear at this point that any assumptions we make are unscientific, unreliable and definitely a waste of time. I think any lab that can create such an amazingly sophisticated product could surely add whatever color they chose to blind the study.

PS Lew, please be careful how far you go grilling your staff, I would hate for the protocol Nazis to change the openness of my clinic.
Lars

Last edited by Lars on Sun Jan 06, 2008 10:56 am, edited 1 time in total.

Lars wrote:The package that has been delivered to the clinic for me waits unopened on the counter until we are ready to inject. The box is opened in front of me, the vials are removed and presented to me so that I can verify the name on them (maybe I should look for someone else's name). The vials are clear glass so that I can see what is inside. I am absolutely sure that at least one of my visits produced "tea colored" vials and the rest seemed clear. I think it is clear at this point that any assumptions we make are unscientific, unreliable and definitely a waste of time. I think any lab that can create such an amazingly sophisticated product could surely add whatever color they chose to blind the study.

This is exactly what happened to me during my injection visits. And same as Lars, on at least one occasion the vials were not clear glass making the serum appear "tea colored". Once it's been loaded into the syringes it then appeared clear. I have seen the procedure list that the nurse uses when giving me my injections and she's following exactly as the list states. I get to watch everything. She always complains that the vials don't hold an extra drop or two of serum since it's impossible to get out every last bit from the vial and the second syringe seems to have slightly less than the amount stated. I watch her fill both syringes and she never overfills the first one.

The first couple of times that I got my injections the vaccine caused a painful feeling in my arms. It basically hurt when the vaccine was going in (NOT when the needle went in), it didn't exactly sting but it hurt. After that the injections never hurt again. It could have been that the temperature of the serum was a little lower or higher than at the other times and caused discomfort (purely speculation on my part). Has anyone else felt anything during the injection?

I have a visit on Jan 16th. I believe it's my last one. On March 1st, my one year in IIB will be up. I assume when I go in this time they'll tell me all about the extension study and what will happen. So far I have had an improvement in my EDSS but I'm not sure exactly how much. I would say it's gone from a 3 down to a 2 during my time in the trial. Next visit I'll ask them for the exact numbers.
I have not had any miraculous recovery but I am better physically than I was prior to going into the trial. Of course this doesn't mean I'm on the vaccine vs. the placebo. It may just be the natural course of the way MS is for me. I still have almost constant tingling in my left arm/hand, muscle weakness in my left leg, and of course getting overheated will cause my EDSS to temporarily spike a few notches. When I kneel down it is very difficult for me to stand up without assistance and if overheated I lose control of my left leg until I'm cooled back down. Before getting into the trial I thought that by now I'd be using a cane constantly. I hope the Tovaxin is working for me but there's no way at this point to know if that's the reason or not.
Thanks for asking!
I'll try to get more details when I go for my appointment later this month.
Take care,
Marcia

I'll stay out of clear/not clear debate. I've seen my serum but I ain't saying as I, like others, don't want to crush the openness of my clinic or ruin the double blind for me or anybody else, though I'm fairly sure that protocol is followed to the letter where I go. I observe my name on the bottle. They look at my driver's license to make sure I'm me—so far I have been every time, but you never know. Follow the times to just about the second. etc etc etc.

What I can offer is that my nurse now changes the needle on the syringe after drawing the vaccine and I have not even felt the poke the last 2 visits. That's 4 shots with pretty big, honkin' needles and not a flinch or wince. My trial nurse is an old hand and just started doing this with her patients and she reports amazing results. I guess jabbing it through the rubber seal dulls it just enough to hurt.

ssmme wrote:The first couple of times that I got my injections the vaccine caused a painful feeling in my arms. It basically hurt when the vaccine was going in (NOT when the needle went in), it didn't exactly sting but it hurt. After that the injections never hurt again. It could have been that the temperature of the serum was a little lower or higher than at the other times and caused discomfort (purely speculation on my part). Has anyone else felt anything during the injection?

I too had an injection or two that really hurt. It may have been shot 3 or 4. Can't recall without looking through my blog.
Most were fine though.

If I were much earlier in the trial my curiousity would be so bad I would continue the clear/tea color issue, but since I am done it doesn't matter much to me anymore. BUT (there is always a but) it is interesting that I have never seen the "stuff" in the vial, only in the syringe.

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